CLA-2 CO:R:C:S 556243 SER
Area Director of Customs
110 S. 4th Street
Room 137
Minneapolis, MN 55401
RE: Protest No. 3501-0-000234, contesting denial of duty-free
treatment for defibrillator pacemakers under subheading
9817.00.96, HTSUSA; Nairobi Protocol; therapeutic
Dear Sir:
The above-referenced protest, filed by Global Transportation
Services, Inc., on behalf of Medtronic, Inc., contests the
assessment of duties by your office on pacemakers referred to as
pacer-cardioverter-defibrillator, under subheading 9021.90.80,
Harmonized Tariff Schedule of the United States Annotated
(HTSUSA). The merchandise at issue was imported from Germany.
FACTS:
The merchandise at issue, referred to as the pacer-
cardioverter-defibrillator (PCD), is a pacemaker which is
designed to treat tachycardia or tachyarrthymia, conditions in
which the heart beats too rapidly or irregularly. Whereas,
conventional pacemakers treat bradycardia, or slow heart beating,
the basic function of both the conventional and defibrillator
pacemakers is identical--the use of electrical signals or pulses
for the stimulation or steadying of the heartbeat or re-
establishing the rhythm of an arrhythmic heart.
ISSUE:
Whether the pacer-cardioverter-defibrillator is eligible
for duty-free treatment under subheading 9817.00.96, HTSUSA.
n -2-
LAW AND ANALYSIS:
The Nairobi Protocol to the Agreement on the
Importation of Educational, Scientific, and Cultural Materials
Act of 1982, established the duty-free treatment for certain
articles for the handicapped. Presidential Proclamation 5978 and
Section 1121 of the Omnibus Trade and Competitiveness Act of
1988, provided for the implementation of the Nairobi Protocol
into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUSA.
These tariff provisions specifically state that "[a]rticles
specially designed or adapted for the use or benefit of the blind
or other physically or mentally handicapped persons" are eligible
for duty-free treatment.
U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUSA, states
that, "the term 'blind or other physically or mentally
handicapped persons' includes any person suffering from a
permanent or chronic physical or mental impairment which
substantially limits one or more major life activities, such as
caring for one's self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working." Clearly,
those individuals who are suffering from heart problems which
mandate the use of pacemakers are encompassed by this note.
U.S. Note 4(b), subchapter XVII, Chapter 98, HTSUSA, which
establishes limits on classification of products in these
subheadings, states as follows:
(b) Subheadings 9817.00.92, 9817.00.94 and 9817.00.96
do not cover--
(i) articles for acute or transient disability;
(ii) spectacles, dentures, and cosmetic articles for
individuals not substantially disabled;
(iii) therapeutic and diagnostic articles; or
(iv) medicine or drugs.
The issue as to whether the defibrillator pacemakers are
"therapeutic" and, therefore, precluded from duty-free treatment
under U.S. Note 4(b), has been raised by your office. The issue
of what constitutes a "therapeutic" article under the Nairobi
Protocol was addressed in Richards Medical Co. v. U.S., 720
F.Supp. 998 (CIT 1989), aff'd, 910 F.2d 828 (Fed.Cir. 1990),
which held that "therapeutic" articles are those that are used to
heal or cure the condition causing a handicap, as opposed to
those articles which are designed to compensate for, or adapt to,
the handicapped condition. In essence, this holding narrowlyn-3-
defines the term "therapeutic", and, as a result, limits the
number of articles which would be precluded from duty-free
treatment under U.S. Note 4(b) as "therapeutic".
The defibrillator pacemakers, as well as conventional
pacemakers, do not heal or cure the underlying heart conditions
of the handicapped individuals who utilize them; they merely
control and help those individuals adapt to their handicapped
conditions. Therefore, the pacemakers at issue are not precluded
from duty-free treatment as "therapeutic" articles under U.S.
Note 4(b).
It should be noted that, as stated above, the basic function
of the defibrillator pacemakers is identical to that of the
conventional pacemakers-- the use of electrical signals or pulses
for the stimulation or steadying of the heartbeat or re-
establishing the rhythm of an arrhythmic heart. Therefore, had
the pacer-cardioverter-defibrillator at issue been ineligible for
duty-free treatment under subheading 9817.00.96, HTSUSA, the
proper classification would be in subheading 9021.50.00, HTSUSA,
which provides for "pacemakers for stimulating heart muscles",
dutiable at the rate of 4.2% ad valorem.
HOLDING:
The defibrillator pacemakers at issue, referred to as pacer-
cardioverter-defibrillator, constitute articles specially
designed for the use or benefit of the physically handicapped
under subheading 9817.00.96, HTSUSA, and would not be precluded
from duty-free treatment on the basis of the exclusion for
"therapeutic" articles. Accordingly, you should grant this
protest in full. A copy of this decision should be attached to
the Customs Form 19, Notice of Action, to be returned to the
protestant.
Sincerely,
John Durant, Director
Commercial Rulings Division